Approval of new pain drug shows the path for analgesic innovation
The new Novartis medicine Adakveo® (crizanlizumab)has just been approved by the FDA to reduce frequency of pain crises in individuals living with sickle cell disease.
I believe this clinical development sets the new paradigm for analgesic innovation.
Moving away from the traditional 10 regulatory paths to approval for analgesics and exploring the over 100 conditions associated with pain is the way increase probability of success in pain drug development.
This is highlighted perfectly by the approval just days ago of Adakveo® (crizanlizumab) which reduces the pain crises in sickle cell disease.
By targeting a high unmet medical need patient group with limited treatment options Adakveo® received Orphan Drug designation followed by breakthrough designation and a priority review from the FDA. The drug was approved based on a single study in under 200 patients and now enters a market where it is estimated to generate $1Billion peak revenues.
Linking research targets to disease from the painlandscape.com and using this patient group in clinical development,
· increases probability of success
· reduces clinical development time
· reduces clinical development cost
· gets analgesics to patient’s faster
· generates revenues quicker
For real analgesic innovation we need to continue to follow the path set by Novartis and not be led into clinical studies in well know pain indications with limited/no translation of preclinical pain models.
Information from press releases:
About the drug
Adakveo® (crizanlizumab) – previously known as SEG101 – is indicated to reduce the frequency of pain crises, in adults and pediatric patients aged 16 years and older with sickle cell disease. It is the first and only targeted biologic that works by binding to P-selectin, a cell adhesion protein that plays a central role in the multicellular interactions that can lead to vaso-occlusion in sickle cell disease.
About the clinical study
SUSTAIN is a randomized, multicenter, placebo-controlled, double-blind study. A total of 198 patients with any genotype of sickle cell disease (HbSS, HbSC, HbS/beta0-thalassemia, HbS/beta+-thalassemia, and others) and a history of 2-10 VOCs in the previous 12 months were eligible for inclusion. Patients were randomized 1:1:1 to Adakveo 5 mg/kg (N = 67), Adakveo 2.5 mg/kg (N = 66), or placebo (N = 65) administered over a period of 30 minutes by intravenous infusion on Week 0, Week 2, and every 4 weeks thereafter, for a treatment duration of 52 weeks.